Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at LMG Cancer & Infusion Center on March 13, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and includes the Conditions under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems D6000 -42 CFR. 493.1403 Laboratory Director D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a tour, review of policies and procedures, instrument performance verification records, manufacturer's instructions for use, daily humidity logs, lack of documentation and interviews, the laboratory failed to: 1. follow their established policy to evaluate/verify the accuracy, precision, reportable range and normal range after installing and initiating patient Complete Blood Count (CBC) testing on the newly installed Sysmex PocH-100i hematology analyzer on November 26, 2024 up to the date of the survey on March 13, 2025. See D5421. 2. document